INVIRASE saquinavir 500mg (as mesilate) film-coated tablet bottle

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

saquinavir mesilate, Quantity: 571.5 mg (Equivalent: saquinavir, Qty 500 mg)

Boleh didapati daripada:

Roche Products Pty Ltd

INN (Nama Antarabangsa):

saquinavir mesilate

Borang farmaseutikal:

Tablet, film coated

Komposisi:

Excipient Ingredients: microcrystalline cellulose; povidone; triacetin; croscarmellose sodium; titanium dioxide; hypromellose; purified talc; iron oxide red; lactose monohydrate; iron oxide yellow; magnesium stearate

Laluan pentadbiran:

Oral

Unit dalam pakej:

120 film coated tablets in white HDPE bottle with plastic screw cap

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

INVIRASE (saquinavir) is indicated for the treatment of HIV/AIDS in adults and children 12 years of age or older. Clinical studies indicate that saquinavir should only be used in combination with ritonavir and other anti-retroviral therapies (see CLINICAL TRIALS). This indication is based on changes in surrogate markers. At present there are no results from controlled clinical trials evaluating the effect of regimens containing saquinavir on HIV disease progression or survival (see CLINICAL TRIALS).

Ringkasan produk:

Visual Identification: Light orange to greyish-brown orange, oval, cylindrical, biconvex flim-coated tablet, with 'SQV 500' on one side and 'Roche' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status kebenaran:

Licence status A

Tarikh kebenaran:

2006-07-07

Risalah maklumat

INVIRASE
®
pronounced "In-vir-ase"
_contains the active ingredient saquinavir_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Invirase tablets. It
does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Invirase
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT INVIRASE IS USED
FOR
Invirase belongs to a group of
medicines called anti-HIV drugs.
Within this group, Invirase belongs
to a class of drugs called HIV
protease inhibitors. Invirase is used
for the treatment of HIV (Human
Immunodeficiency Virus). It works
by interfering with the viral
reproductive cycle.
Invirase must be used only in
combination with ritonavir (Norvir
®
)
and other medicines to treat the HIV
virus.
Please note that you should always
report any changes in your condition
to your doctor to ensure that any
infections which occur due to your
low immunity (called opportunistic
infections) are treated promptly.
Your doctor may have prescribed
Invirase for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY INVIRASE HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
Invirase is not a cure for HIV
infection and you may continue to
acquire illnesses associated with
advanced HIV infection, including
opportunistic infections.
Invirase does not reduce the risk of
transmitting HIV to others through
sexual contact or contamination
through blood.
BEFORE YOU TAKE
INVIRASE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE INVIRASE IF:
1.
YOU HAVE ALLERGIES TO SAQUINAVIR
OR ANY INGREDIENTS LISTED AT THE
END OF THIS LEAFLET
2.
YOU HAVE SEVERE LIVER DISEASE
3.
IF YOU WERE BORN WITH OR HAVE:
•
any condition with abnormal
electrocardiograms (ECG-
electrical re

Ciri produk

AUSTRALIAN PRODUCT INFORMATION
INVIRASE
® (SAQUINAVIR MESILATE)
Invirase 180906
1
1.
NAME OF THE MEDICINE
Saquinavir mesilate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Invirase film-coated tablets contain 571.5 mg of saquinavir mesilate
equivalent to 500 mg
saquinavir free base.
Excipients with known effect
Lactose monohydrate
For the full list of excipients, see section 6.1.
Note: Saquinavir soft gel capsules (Fortovase) are no longer marketed
in Australia.
3.
PHARMACEUTICAL FORM
Invirase 500 mg film-coated tablets are light orange to brownish
orange, oval, cylindrical and
biconvex. The tablets are marked “SQV 500” on one side and
“ROCHE” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Invirase (saquinavir) is indicated for the treatment of HIV/AIDS in
adults. Saquinavir must
be used only in combination with ritonavir and other antiretroviral
therapies (see section 5.1).
This indication is based on changes in surrogate markers. At present
there are no results from
controlled clinical trials evaluating the effect of regimens
containing saquinavir on HIV
disease progression or survival (see section 5.1).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Invirase must be given in combination with ritonavir
(ritonavir-boosted Invirase). Please also
see the complete product information for ritonavir.
The recommended dose of Invirase
is 1000 mg twice daily (2000 mg total daily dose) with
ritonavir 100 mg twice daily in combination with other antiretroviral
agents.
For treatment-naïve patients initiating treatment with Invirase, the
recommended starting
dose of Invirase is 500 mg twice daily with ritonavir 100 mg twice
daily for the first 7 days of
treatment. After 7 days, the recommended dose of Invirase is 1000 mg
twice daily with
ritonavir 100 mg twice daily.
Patients switching immediately from treatment with another protease
inhibitor (PI) taken with
ritonavir or from a non-nucleoside reverse transcriptase inhibitor
(NNRTI) based regimen,
Invirase 180906
2
except rilpivirine (see section